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K2M receives FDA clearance and CE mark for new interbody system
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K2M Group Holdings Inc. recently announced it received 510(k) clearance from the FDA to market its CASCADIA Lateral Interbody System featuring the company’s proprietary Lamellar Titanium Technology.
In addition, the new product received a CE mark, which allows for global availability of the system, according to a press release.
The new lateral interbody system uses 3-D printing with the goal of allowing for bony integration throughout an implant. With the use of titanium powder, the implants are grown through the selective application of a high-energy laser beam. This process incorporates both porosity and surface roughness that pre-clinical data have associated with bone growth activity, according to a release.
“We are pleased to receive FDA 510(k) clearance and a CE mark for the CASCADIA Lateral Interbody System, further expanding the offering of our proprietary Lamellar Titanium Technology, which uses 3-D printing and is designed to allow for bony on growth and ingrowth,” Eric Major, president and chief executive officer of K2M, said in a press release. “These regulatory milestones, coupled with the successful completion of the first surgical case late last year, underscore our commitment to expanding our minimally invasive spine portfolio by bringing innovative and differentiated technologies and products to the global spine market.”
The system includes a full range of implant sizes and is designed to work in conjunction with the RAVINE Lateral Access System, according to a release.
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